Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
研究概览
简要总结
The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day or 800mg/day or 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.
详细描述
Oxidative Stress (OS) plays a key role in aging and neurodegenerative diseases, including Alzheimer's Disease. The brain's primary antioxidant, GSH, is essential for combating Reactive Oxygen Species (ROS).This study is designed as an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of GGC supplementation in patients with MCI. This will enable the investigators to identify maximum tolerated or recommended dose for further clinical evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Memory complaints;
- •MCI diagnosis
- •MoCA score between 18-25
- •Age 55 - 80 years old.
- •Ability to read and write in English
排除标准
- •Subjects with a history of cancer;
- •Subjects with a history of schizophrenia, manic-depressive disorder
- •Subjects on antioxidant therapy (ashwagandha, gingko biloba, N-acetylcysteine or glutathione)
- •Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse/dependence;
研究组 & 干预措施
Gamma - Glutamylcystiene 400
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.
干预措施: Gamma- Glutamylcysteine (Drug)
Gamma - Glutamylcystiene 800
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months
干预措施: Gamma- Glutamylcysteine (Drug)
Gamma - Glutamylcystiene 1200
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months
干预措施: Gamma- Glutamylcusteine (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
时间窗: 3 months
Safety and Tolerability
Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.
时间窗: 3 months
Safety and tolerability
Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.
时间窗: 3 months
Safety and tolerabitily
Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.
时间窗: 3 months
Safety and tolerability: The number of participants experiencing clinically significant abnormal laboratory test results (hematology, kidney, and liver function tests) during 3 months of GGC supplementation, compared with baseline.
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.
时间窗: 1 month
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
次要结局
- Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.(3.5 months)
- Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.(3.5 months)
研究者
Pravat Mandal
Research Professor
University of Pittsburgh